Medical Innovation Acceleration Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 6925 To amend the Federal Food, Drug, and Cosmetic Act to exempt from regulation as devices non-invasive diagnostic devices, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 19, 2020 Mr. BIGGS introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to exempt from regulation as devices non-invasive diagnostic devices, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medical Innovation Ac- 4 celeration Act of 2020’’. 5 SEC. 2. EXEMPTING NON-INVASIVE DIAGNOSTIC DEVICES 6 FROM REGULATION AS DEVICES. 7 Section 201(h) of the Federal Food, Drug, and Cos- 8 metic Act (21 U.S.C. 321(h)) is amended— 9 VerDate Sep 11 2014 23:11 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6925.IH H6925 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 6925 IH (1) in the second sentence by inserting before 1 the period at the end the following: ‘‘or any non- 2 invasive diagnostic device’’; and 3 (2) by adding at the end the following: ‘‘For 4 purposes of the preceding sentence, the term ‘non- 5 invasive’ means, with respect to a diagnostic device, 6 that the device does not penetrate the skin or any 7 other membrane of the body, is not inserted or im- 8 planted into the body, causes no more than ephem- 9 eral compression or temperature changes to in situ 10 bodily tissues, and does not subject bodily tissues to 11 ionizing radiation.’’. 12 Æ VerDate Sep 11 2014 23:11 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H6925.IH H6925 kjohnson on DSK79L0C42PROD with BILLS